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Clinical Trials in China / NCT05918445
Recruiting Phase 1/2

PM8002 in the Treatment of Patients With Advanced Solid Tumors

NCT05918445 · tracked via the Priya Life Science China tracker
Sponsor
Biotheus Inc.
Phase
Phase 1/2
Started
2021-03-09
Last updated
2024-12-05

Condition(s) studied

Malignant Neoplasm

Investigational drug(s) / intervention(s)

PM8002

PM8002: IV infusion

Study summary

This study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of PM8002, a PD-L1/VEGF bispecific antibody, as a single agent in adult subjects with advanced solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures; 2. Male or female aged 18 to 75 years; 3. Patients with malignant tumor confirmed by histology or cytology; 4. The toxicity of previous anti-tumor therapy has not been alleviated; 5. Adequate organ function; 6. ECOG score was 0-1; 7. Expected survival \>=12 weeks; 8. According to RECIST 1.1 criteria, at least 1 measurable lesion that has not been previously treated locally. Exclusion Criteria: 1. History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study; 2. Evidence of major coagulopathy or other obvious risk of bleeding; 3. Patients are experiencing a clear interstitial lung disease or non-infectious pneumonia, unless it is caused by local radiotherapy; 4. Patients with uncontrolled brain metastases should be excluded from this clinical trial; 5. Patients ever experienced other active malignant tumors within 5 years prior to the study treatment; 6. Prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 7. Known history of alcohol abuse, psychotropic drug abuse or drug abuse; 8. Syphilis antibody positive; 9. Patients with active tuberculosis (TB) are excluded; 10. Pregnant or lactating women; 11. Other conditions lead to inappropriate to participate in this study as judged by the investigator.

Primary outcome measure(s)

Trial sites (48)

FacilityCityRegionStatus
Baoji Central Hospital Baoji China Recruiting
Baoji Central Hospital Baoji China Recruiting
Cancer Hospital Chinese Academy of Medical Sciences Beijing China Recruiting
Peking University Cancer Hospital Beijing China Recruiting
Peking University Cancer Hospital Beijing China Recruiting
Jilin Cancer Hospital Changchun China Recruiting
The First Hospital of Jilin University Changchun China Recruiting
Changde First People's Hospital Changde China Recruiting
Hunan Provincial People's Hospital Changsha China Recruiting
The First People's Hospital of Changzhou Changzhou China Recruiting
Chengdu Integrated TCM& Western Medicine Hospital Chengdu China Recruiting
Sichuan Cancer Hospital Chengdu China Recruiting
Chongqing Cancer Hospital Chongqing China Recruiting
Chongqing Cancer Hospital Chongqing China Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing China Recruiting
The Southwest Hospital of AMU Chongqing China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Zhejiang Provincial People's Hospital Hangzhou China Recruiting
Harbin Medical University Cancer Hospital Harbin China Recruiting
Anhui Provincial Hospital Hefei China Recruiting
Linyi Cancer Hospital Linyi China Recruiting
Jiangsu Province Hospital Nanjing China Recruiting
Jiangsu Province Hospital Nanjing China Recruiting
Shanghai Orient Hospital Shanghai China Recruiting
Shanghai Sixth People's Hospital Shanghai China Recruiting
Shengjing Hospital of China Medical University Shengjing China Recruiting
Liaoning Cancer Hospital Shenyang China Recruiting
The First Hospital of China Medical University Shenyang China Recruiting
The People's Hospital of Liaoning Province Shenyang China Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang China Recruiting
Shanxi Bethune Hospital Taiyuan China Recruiting
Shanxi Provincial Cancer Hospital Taiyuan China Recruiting
Shanxi Provincial Cancer Hospital Taiyuan China Recruiting
Taizhou Hospital of Zhejiang Province Taizhou China Recruiting
The Second Hospital of Tianjin Medical University Tianjin China Recruiting
Hubei Cancer Hospital Wuhan China Recruiting
Hubei Cancer Hospital Wuhan China Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University Xi'an China Recruiting

+ 8 more sites — see the full list on the official registry below.

More Biotheus Inc. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05918445 on ClinicalTrials.gov ↗ ← All trials in China